None of this requires bad faith. It requires only ordinary pressure—a deadline, a vendor contract, a steering committee asking when the old license can be cancelled—and the universal human tendency to confuse motion with progress. The regulator, however, does not grade effort. The regulator inspects records. And if the records are incomplete, if the audit trail has a gap, if a user signed something in a system that was not validated for that purpose on the date in question, the consequences live in the inspection report long after the new platform's vendor logo has stopped appearing on internal slides.

This lesson treats technology transitions as what they are: high-risk regulated events that demand the same rigor as the trial conduct they support. We will build the migration plan, evaluate it for compliance risk, and ground every choice in ICH E6(R3) Annex 1—because Annex 1 is precisely where the guideline addresses what computerised systems must do, and what their custodians must prove.

None of this requires bad faith. It requires only ordinary pressure—a deadline, a vendor contract, a steering committee asking when the old license can be cancelled—and the universal human tendency to confuse motion with progress. The regulator, however, does not grade effort. The regulator inspects records. And if the records are incomplete, if the audit trail has a gap, if a user signed something in a system that was not validated for that purpose on the date in question, the consequences live in the inspection report long after the new platform's vendor logo has stopped appearing on internal slides.

This lesson treats technology transitions as what they are: high-risk regulated events that demand the same rigor as the trial conduct they support. We will build the migration plan, evaluate it for compliance risk, and ground every choice in ICH E6(R3) Annex 1—because Annex 1 is precisely where the guideline addresses what computerised systems must do, and what their custodians must prove.